# K894854: QCT Bone Mineral Density Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Image Enhancements
- Decided: Oct 19, 1989 after 80 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip (2001), 11 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K121716: TBS Insight (2012), 5 descendants of its own
- K152299: TBS iNsight (2016), 4 descendants of its own
- K213760: ABMD Software (2022), 2 descendants of its own

Source page: https://510kreport.com/device/K894854
Methodology: https://510kreport.com/methodology